Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Product NDC
16571-754
Requested package NDC
16571-754-53
11-digit product format
165710754
Labeler code
16571
Product ID
16571-754_48173c90-79ed-459d-b259-947bc7952c13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rising Pharma Holdings, Inc.
Application
NDA050417
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-04-07
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
4 mg/g; [USP'U]/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16571-75416571-754-53DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16571-75416571-754-53DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050417-001LUMI-SPORYNBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050417-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050417-001LUMI-SPORYN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050417-001LUMI-SPORYN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050417-001LUMI-SPORYN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050417-001LUMI-SPORYN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GMOINTMENT / OPHTHALMICATRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GMOINTMENT / OPHTHALMICATRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050417-001NEOSPORIN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050417-001NEOSPORIN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N050417-001NEOSPORIN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N050417-001NEOSPORIN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050417-001LUMI-SPORYNEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050417-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050417-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050417-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050417-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050417-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050417-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050417-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050417-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050417-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050417-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050417-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050417-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050417-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050417-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050417-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050417-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050417-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050417-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050417-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050417-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050417-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N050417-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050417-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050417-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050417-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N050417-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050417-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050417-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050417-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050417-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050417-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050417-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050417-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050417-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050417-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050417-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050417-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050417-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050417-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050417-001AT1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-754-53GM - Gram16571-754cafe3402-a8f4-4adc-bd88-219b8c236c7812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-754NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [RISING PHARMA HOLDINGS, INC.]1Legacy NDC20211117_48173c90-79ed-459d-b259-947bc7952c13.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-754-53165710754531 TUBE in 1 CARTON (16571-754-53) > 3.5 g in 1 TUBE1 tube2021-11-010000-00-00NoNoCurrent